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1.—(1) These Regulations may be cited as the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 and shall come into force on 1st September 2006.
(2) In these Regulations—
“the Act” means the Human Tissue Act 2004;
“donor” and “recipient” have the meaning given by regulation 4; and
“research ethics authority” means—
an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004(1), or
any other committee established or person appointed—
to advise on, or on matters which include, the ethics of research investigations on relevant material which has come from a human body, and
recognised for that purpose by, or on behalf of, the—
Secretary of State,
National Assembly for Wales, or
Department of Health, Social Services and Public Safety;
“transplantable material” has the meaning given in regulation 9 of the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006(2).
2. Research is ethically approved for the purposes of section 1(9)(a) and paragraph 10(b) of Schedule 4 to the Act where it is approved by a research ethics authority.
3.—(1) The storage of relevant material by a person who intends to use it for a scheduled purpose is excepted from section 16(2)(e)(ii) of the Act (storage of relevant material which has come from a human body) in the circumstances set out in paragraphs (2) to (4).
(2) Storage of relevant material which has come from the body of a living person is excepted where the person storing it is intending to use it for—
(a)any purpose specified in paragraphs 2 to 5 or 8 to 12 of Part 1 of Schedule 1 to the Act (determining the cause of death, establishing after a person’s death the efficacy of any drug or treatment administered to him, obtaining information which may be relevant to another person, public display, clinical audit, education or training relating to human health, performance assessment, public health monitoring, quality assurance); or
(b)the purpose of qualifying research.
(3) Storage of relevant material which has come from a human body is excepted where the person storing it is intending to use it for the purpose of transplantation and—
(a)the material is an organ or part of an organ if it is to be used for the same purpose as the entire organ in the human body; or
(b)the storage is for a period of less than 48 hours.
(4) Storage of relevant material which has come from the body of a deceased person is excepted where—
(a)the person storing it is intending to use it for the purpose of qualifying research; or
(b)the relevant material—
(i)has come from premises in respect of which a licence under section 16(2) is in force,
(ii)is stored by a person intending to use it for the sole purpose of analysis for a scheduled purpose other than research, and
(iii)will be returned to premises in respect of which a licence under section 16(2) is in force when the analysis is completed.
(5) In this regulation—
(a)“organ” means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy;
(b)“qualifying research” means—
(i)research which is ethically approved for the purposes of section 1(9)(a) of the Act; or
(ii)a specific research project for which such ethical approval is pending;
(c)an application for ethical approval is pending from when it has been submitted to a research ethics authority until the decision of the authority has been communicated to the applicant.
4. A person who has removed transplantable material from a human body (“the donor”) which is proposed to be transplanted to another person (“the recipient”) shall supply to NHS Blood and Transplant(3) the information specified in Schedule 1 to these Regulations.
5. A person who has received transplantable material which is proposed to be transplanted to a recipient shall supply to NHS Blood and Transplant the information specified in Schedule 2 to these Regulations.
Minister of State,
Department of Health
25th April 2006
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